- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03447444
Music and Physical Activity in Persons With Dementia
September 14, 2020 updated by: Dagfinn Nåden, Oslo Metropolitan University
Dignity for Persons With Dementia and Signs of Frontotemporal Affection in Institutions.See us and Dance With us
Fronto lobe dementia constitutes 10-20 % of dementia conditions within younger persons (>65).
People with neuronal degeneration in frontal and temporal lobes demonstrate a decline in social conduct, apathy, loss of insight that is gradual and progressive.
Family members often experience guilt and shame because of the patients' behavior before institutionalization, and different behavioral disorders will cause great challenges to family caregivers and to staff after institutionalization. Preservation of dignity, both in regards to the person being affected, and their relatives, therefore seem highly relevant both before and after institutionalization.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study was to evaluate whether a combined intervention of physical activity and music therapy could reduce restlessness, irritability, and aggression among institutionalized people with severe dementia.
An exploratory design was used to evaluate a combined intervention of physical activity, music therapy, and in- or outdoors walking daily, systematically implemented for eight weeks for persons with severe dementia in institutional care.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Oslo, Norway, 0130
- Oslo Metropolitan University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:Persons with dementia with symptoms of frontal lobe dementia, who had lived for at least 6 months in a unit special care dementia unit in a nursing home
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Exclusion Criteria:
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: music and physical activity
An intervention consisting of physical activity, music and walking, was systematically implemented for eight weeks
|
This feasibility study focus on promoting a combination of music therapy and physical activity with the primary goal to describe the influence on restlessness, irritability, and aggression in persons with severe stage of dementia with a mixture of symptoms including frontal lobe problems in institutional care.
A secondary goal is to investigate the treatment fidelity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brøset Violence Checklist
Time Frame: change from baseline to eight weeks into intervention
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The BVC assesses the presence of six observable patient behaviors, namely whether the patient is confused, irritable, boisterous, verbally threatening, physically threatening, and/or attacking objects
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change from baseline to eight weeks into intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychiatric Inventory
Time Frame: baseline
|
The Neuropsychiatric Inventory-Questionnaire [NPI-Q] is a clinical instrument for assessing behavioral and psychological symptoms in dementia
|
baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dagfinn Nåden, PhD, Oslo Metropolitan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2014
Primary Completion (Actual)
February 27, 2015
Study Completion (Actual)
February 27, 2015
Study Registration Dates
First Submitted
January 22, 2018
First Submitted That Met QC Criteria
February 26, 2018
First Posted (Actual)
February 27, 2018
Study Record Updates
Last Update Posted (Actual)
September 16, 2020
Last Update Submitted That Met QC Criteria
September 14, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Frontallob dementia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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